UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011400 |
|---|---|
| Receipt number | R000013348 |
| Scientific Title | Establishment of a novel preoperative brain mapping system by navigated transcranial magnetic stimulation (nTMS) |
| Date of disclosure of the study information | 2013/08/08 |
| Last modified on | 2014/01/26 13:43:12 |
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Basic information
Public title
Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Acronym
Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Scientific Title
Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Scientific Title:Acronym
Establishment of a novel preoperative brain mapping system
by navigated transcranial magnetic stimulation (nTMS)
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the safety and effectiveness of preoperative nTMS before awake surgery for the identification of areas of language, motor and cognitive function in patients with brain tumors. Moreover, we aimed to establish a novel preoperative brain mapping system by nTMS by comparing the results from nTMS with direct cortical stimulation during awake cranitomy.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Any disturbance of speech, movement and cognitive function processing
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Navigated transcranial magnetic stimulation
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Aged 20 to 70 years old
2) The patients who are planned to take a surgery for brain tumors that are associated with areas of language, motor and cognitive function
Key exclusion criteria
1) No cognitive disorders, aphasia, psychiatric disorders, higher brain dysfunctions
2) Those having heart pacemaker or drug infusion pomp
3) Those having severe heart diseases
4) Those having the deep brain stimulation or the spinal cord stimulation
5) Pregnant or intend to be pregnant
6) the patients who are excluded by doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuya MOTOMURA |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2353
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuya MOTOMURA |
Organization
Nagoya University Graduate School of Medicine
Division name
Department of Neurosurgery
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya 466-8550, Japan
TEL
052-744-2353
Homepage URL
kmotomura@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Neurosurgery, Nagoya University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Open public recruiting
Date of protocol fixation
| 2013 | Year | 07 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 24 | Day |
Last follow-up date
| 2018 | Year | 07 | Month | 23 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 08 | Month | 07 | Day |
Last modified on
| 2014 | Year | 01 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013348
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
